The Institutional Review Board is a local review board, established by the Western Michigan University Board of Trustees in accord with federal regulations, to interpret and apply federal regulations, ...
The ethics of human-subjects research has captured scientific and regulatory attention for half a century. Honoring the Belmont Report’s principles—respect for persons, beneficence, and justice—ought ...
The death of a young man, Jesse Gelsinger, in a 1999 gene therapy experiment has focused attention on the challenges of research with human subjects. This issue had been simmering just below the ...
The US Food and Drug Administration (FDA) on Tuesday issued two proposed rules aimed at harmonizing certain sections of the agency’s regulations on human subject protections and Institutional Review ...
This chapter presents a brief summary of the federal regulations governing the protection of human subjects in research, with particular attention to how the concepts of the regulations fit with the ...
I worked for 20 years for the HHS office that safeguarded people in research studies. DOGE gutted it
Pritchard worked in the Office for Human Research Protections for 20 years and retired as the senior adviser to the director of OHRP in 2024. Deciding whether to participate in a clinical research ...
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Human subject means a living ...
Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or Obtains, uses, studies, analyzes, or ...
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